A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

The purpose of this Phase 2/3, randomized, multisite, open-label, dose confirmation, and expansion study is to evaluate the safety, and efficacy of zilovertamab vedotin (ZV) in combination with standard of care options for the treatment of rrDLBCL. This study will be divided into 2 parts: Dose Confirmation (Part 1) and Efficacy Expansion (Part 2) and will enroll participants who are at least 18 years of age with rrDLBCL. The hypotheses are: ZV in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx) is superior to R-GemOx with respect to progression-free survival (PFS) per Lugano

Trial Details

NCT ID

NCT05139017

Phase

PHASE2 / PHASE3

Sponsor

Merck Sharp & Dohme LLC

Status

RECRUITING

Cancer Type

Non-Hodgkin Lymphoma Lymphoma

Interventions

Zilovertamab vedotin
Rituximab
Gemcitabine
Oxaliplatin
Bendamustine
Granulocyte Colony-Stimulating Factor (G-CSF)

Locations (sample)

Glendale, Arizona, United States|33.53865,-112.18599
Beverly Hills, California, United States|34.07362,-118.40036
Walnut Creek, California, United States|37.90631,-122.06496
Whittier, California, United States|33.97918,-118.03284
Boca Raton, Florida, United States|26.35869,-80.0831

Key Eligibility Criteria

Has a histologically confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL).
Has radiographically measurable DLBCL per the Lugano Response Criteria, as assessed locally by the investigator.
Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 within 7 days prior to study treatment initiation.
Has adequate organ function.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Non-Hodgkin Lymphoma Lymphoma Trials on Trialify →